Plan B is Over the Counter, why not Plan A?

The work to move birth control over the counter must be done in parallel to the work advocating for legal abortion. Both are equally important, and neither negates the other.

On July 11, France-based HRA Pharma submitted their Prescription-to-Nonprescription (Rx to OTC) Switch Application to the FDA, hoping to be the first providers of an over-the-counter oral birth control in the United States. The drug is currently on the market as OpillTM and requires a prescription, whereas the company’s UK version, under the name Hana, is available without a doctor’s order. 

OpillTM is a progesterone only pill or “minipill”, rather than a combination of progesterone and estrogen. The active ingredient is a synthetic progesterone called norgestrel, which works to prevent pregnancy by preventing ovulation and thickening the cervical mucus. During the normal menstrual cycle, fluctuations in estrogen and progesterone signal to the body that it should either prepare for a pregnancy or reset the cycle. 

These hormones communicate through a negative feedback system with other parts of the body, including the brain. This system is called the Hypothalamic-Pituitary-Gonadal (HPG) Axis.. In this process, the hypothalamus signals to the pituitary, which in turn communicates to the gonads (in this case, the ovaries), which produce estrogen and progesterone. When the body senses these hormones, it signals back to the hypothalamus  to stop signaling the pituitary, hence the name negative feedback. 

By adding exogenous (“outside the body”) progesterone, the feedback loop that exists between the brain and the reproductive system senses the presence of progesterone and downregulates the actions of the hypothalamus. In doing so, it also downregulates another important hormone called luteinizing hormone (LH), which is responsible for ovulation and ovulation is blocked.

Oral birth control has been around for over sixty years, and progesterone only pills are safe for the majority of reproductive-aged patients, including those who should not take the combination, estrogen-containing pill. This may give HRA Pharma an advantage in the approval of their application, which is expected to be under review for the next ten months.

HRA Pharma’s application followed on the heels of the Supreme Court’s June 24th ruling in Dobbs v. Jackson that overturned federal protection of abortion. With abortion now restricted or banned in many states, the potential for over-the-counter birth control is certainly invigorating news in the push for reproductive justice. However, improving birth control access will not negate the need for comprehensive, safe, and informed sexual healthcare, including abortion. 

The pill’s 91% efficacy in real world use is great. But what about the  9% of people who have a birth control failure? The work to move birth control over the counter must be done in parallel to the work advocating for legal abortion. Both are equally important, and neither negates the other. As one of my previous professors said, “As long as people are having sex, we will need abortions.”

That being said, moving OpillTM and other pills over-the-counter is an important step in achieving accessible, equitable health care. Eliminating barriers to using the birth control pill will empower people to control their own fertility. Historically, contraception, and the pill specifically, has been used to suppress vulnerable populations. Shifting oral contraceptives over-the-counter can alleviate hesitation in seeking a prescription and having to juggle a provider’s prejudice. It also reduces barriers such as taking time off work or finding alternative family care arrangements that are necessary when making an appointment at a physician’s office.

There is so much to benefit from OpillTM potentially coming onto pharmacy shelves, and we hope that HRA Pharma’s data, collected with help from Ibis Reproductive Health and others in the Free the Pill Coalition, will be enough to prove the safety and efficacy to the FDA. 

From the Dalkon Shield to Britney’s IUD

The answer is that the reproductive health of people who can get pregnant is simply not a high enough priority in our society. We settle for good enough when we could have great. 

Last week Britney Spears described how under her conservatorship, she was required to be fitted with an intrauterine device and is prohibited from removing it without her father’s permission or the permission of the court. Presumably the goal was to stop Ms. Spears from becoming pregnant with additional children without the express authorization of her custodian. 

Britney Spears from her Instagram Page.

There are many discussions to have about Ms. Spears’ rights, disability rights, and forced reproductive control. The topic is an intersectional minefield. An amazing discussion with a journalist who is an expert in the field and who has a disability was broadcast on What Next this week. My own thoughts on the subject would require me to use profanity on a blog that I know is read by my program manager at the NIH, and when I resort to profanity, that usually means I am out of comfortable intellectual waters. What I can discuss with a fair amount of authority is the IUD itself, its history in modern times, and how it has succeeded and failed as a medical device for people who want to avoid pregnancy. 

If you are my age (49) or older, you first learned about the IUD from horror stories told about the Dalkon Shield. The Dalkon Shield was an IUD invented in the early 1970’s by a gynecologist. Hugh J. Davis, was known as an intellectually arrogant person who didnt take criticism well.  So, it wasn’t a very inclusive design team – just one man. He later recruited Irwin Lerner, an electrical engineer, to help him finalize and market the device.  The device was rushed to market with insufficient clinical data, and the inventors published their pre-market data without acknowledging their financial interests in the device. They sold the device design to the A.H. Robins company, and Davis continued to act as a consultant and proponent of the device for many years. 

At the time, the birth control was popular, but the high levels of hormones in those pills were concerning to many.  The side effects of the pill were and still are troublesome and sometimes very serious. In the 1970’s, the available pills nearly 100 times more progestin and 3 to five times as much estrogen as what typical combination pills contain today.  Second, and probably more important, is the fact that the A.H. Robbins company did something new that we now take for granted: they marketed the ever loving heck out of that device. 

Dalkon Shield Marketing Material

Before 1976, you could invent and patent a new medical device that was meant to be inserted inside a uterus and worn for years at a time with absolutely no federal oversight. As a result, there were no regulations that limited or specified the set of materials to be used to construct the device. So, when the company decided to use a new material for the string, they were able to make that change without consulting any oversight body or performing additional testing to make sure that it was safe. 

It turns out that the filament they used for the string was made up of several smaller filaments, like a cable consisting of several smaller wires wrapped together. The little spaces in between the multi-filament string were small enough to give bacteria from the vagina a pathway into the uterus. These bacteria caused infections in people wearing the device that were later recognized as pelvic inflammatory disease. All told, the Dalkon Shield resulted in the injury of hundreds of thousands of women and the documented deaths of at least 18. 

The Dalkon Shield disaster is why medical devices are now regulated by the FDA, due to a federal law passed in 1976. Prior to 1976, only drugs were regulated. 

As a result of the Dalkon Shield injuries, deaths, and related lawsuits and finally recall, IUDs fell out of fashion in the US. Even though many other non-Dalkon devices existed, the market for IUDs was non-existent. The FDA approved the first new generation IUD in 1984, and that device was available in the US in 1988. Then several years passed before the current crop of modern IUDs began to come on the market from 2001-2016. These are considered Class III medical devices and require pre-market approval before they can be sold in the US. 

If a device failure occurs, doctors and patients are encouraged to report the failure to the FDA. Only distributors and manufacturers are required to report. The FDA compiles a database of these failures and though the reporting system is largely voluntary, the FDA does investigate to see if they are part of a pattern. Even the devices containing copper are considered to contain a drug, so must undergo stricter regulations required of drug/device combination products. Most agree that this has led to a very safe but short list of new generation IUDs available in the US. The downside of this enhanced regulation is that many devices approved in other countries that may be more appropriate for some people are not available here. The cost of obtaining FDA approval is too high to make selling in the US market attractive to foreign manufacturers. 

The stain of the Dalkon Shield has faded a bit. Younger people are more likely to seek and IUD as a long-term reversible form of birth control.  However, the legacy of birth control designed, developed, and marketed by people who cannot become pregnant is still a part of medical care today.  All the highly effective birth control methods have undesirable side effects. (Well, maybe not vasectomies, but that requires a monogamous relationship with someone with a good amount of self-knowledge and foresight for maximum efficacy – a rare situation). 

Everyone else must figure out what side effects and inconveniences we are willing to deal with to manage when we do and do not want to bear children, if at all. Why is the situation so dire? Why do we take the pill and risk life threatening blood clots at rates that are higher than those that temporarily stopped the use of some vaccines during a global pandemic? The answer is that the reproductive health of people who can get pregnant is simply not a high enough priority in our society. We settle for good enough when we could have great. 

One way to make better contraceptive choices a priority is to have people who can become pregnant directly involved with the design and development of contraceptive devices. Involved from the earliest stages. We need the viewpoints of these people as patients and as clinicians, designers, and engineers.  And we all need to think just a little more about each other’s healthcare. 

Simply, when the people who are the main users of a technology are not consulted in the design phase of that technology, the results for the end users are subpar and sometimes outright harmful. 

Diverse teams can save lives.   

As for Ms. Spears, it seems clear that her autonomy has been robbed without due process. Since you cannot remove an IUD on your own, she is effectively at the mercy of the state with respect to her ability to bear more children. Medical science may have given her a safer device than was available in the 70’s, but disability law has kept her rights in the 1920’s.